Evolocumab Side Effects

For the Consumer

Applies to evolocumab: subcutaneous solution

Side effects requiring immediate medical attention

Along with its needed effects, evolocumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking evolocumab:

Incidence not known

• Difficulty with breathing or swallowing
• fever
• hives, itching, or rash
• nausea
• reddening of the skin, especially around the ears
• swelling of the eyes, face, or inside of the nose
• unusual tiredness or weakness

Side effects not requiring immediate medical attention

Some side effects of evolocumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• blurred vision
• body aches or pain
• chills
• cough
• dry mouth
• ear congestion
• flushed, dry skin
• fruit-like breath odor
• headache
• loss of voice
• muscle aches
• sneezing
• sore throat
• stomach ache
• stuffy or runny nose
• sweating
• troubled breathing
• unexplained weight loss
• vomiting

Less common

• Bladder pain
• bloody or cloudy urine
• diarrhea
• difficult, burning, or painful urination
• difficulty with moving
• dizziness
• frequent urge to urinate
• loss of appetite
• lower back or side pain
• muscle or joint pain
• muscle stiffness
• nervousness
• pain or tenderness around the eyes and cheekbones
• pounding in the ears
• slow or fast heartbeat
• swollen joints

For Healthcare Professionals

Applies to evolocumab: subcutaneous solution

General

The more commonly reported adverse reactions have included nasopharyngitis, upper respiratory tract infection, back pain, and injection site reactions.

Hypersensitivity

Common (1% to 10%): Hypersensitivity reactions (including rash, eczema, erythema, urticaria)

Postmarketing reports: Angioedema^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, gastroenteritis, nausea (1.8%)^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection^[Ref]

Local

Common (1% to 10%): Injection site reaction (including erythema, pain, bruising)^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, myalgia, musculoskeletal pain, arthralgia (1.8%)^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Neurocognitive events (0.2%)^[Ref]

Other

Common (1% to 10%): Influenza, fatigue (1.6%)

Uncommon (0.1% to 1%): Contusion^[Ref]

Respiratory

Common (1% to 10%): Influenza, fatigue (1.6%)

Uncommon (0.1% to 1%): Contusion^[Ref]

Immunologic

Rare (less than 0.1%): Development anti-drug antibody^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer